A Study of Non-invasive Measurement of Blood Glucose and Blood Pressure
NCT ID: NCT05904769
Last Updated: 2025-10-08
Study Results
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View full resultsBasic Information
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TERMINATED
NA
87 participants
INTERVENTIONAL
2023-05-31
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Hospitalized Diabetic Group
Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, will wear the LIFELEAF Smartwatch for the duration of their hospital stay.
LIFELEAF Smartwatch
Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.
Electrophysiologic (EP) Group
Subjects undergoing an EP procedure will wear he LIFELEAF Smartwatch for the duration of the procedure.
LIFELEAF Smartwatch
Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.
Interventions
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LIFELEAF Smartwatch
Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing continuous monitoring for heart rate, ECG and blood pressure as part of their routine care.
* Patients undergoing invasive and noninvasive electrophysiologic procedures.
Exclusion Criteria
* Patients without arms as these are needed to wear the wrist-based sensor.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Narayan (Guru) G. Kowlgi
Principal Investigator
Principal Investigators
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Narayan Guru G. Kowlgi, MBBS
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Minnesota
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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22-010799
Identifier Type: -
Identifier Source: org_study_id
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